MERCATI: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
AREE TERAPEUTICHE DI COMPETENZA (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
COMPLIANCE: ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), Servizio pubblico francese (CIR), TGA (Australia GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), ISO, Health Canada (Canada GMP), MFDS/KFDA (Repubblica di Corea GMP)
SOSTANZE CONTROLLATE: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGIONE: Europe
USO: Umano
SERVIZI: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)